Rush University Medical Center First to Enroll Patient in the Gore REDUCE Clinical Study for the Indication of Patent Foramen Ovale (PFO) Closure
11 December 2008 - Multi-national trial to demonstrate safety, effectiveness of GORE HELEX Septal Occluder for PFO closure in patients with a history of cryptogenic stroke

Gore Receives Approval from FDA for Unique Patent Foramen Ovale Stroke Study
05 May 2008 - Multinational trial randomizes stroke patients with Patent Foramen Ovale (PFO) to closure with the GORE HELEX Septal Occluder versus medical management

Gore Provides Update on Patent Foramen Ovale (PFO) Stroke Study
08 July 2010 - Gore Reaffirms Commitment to Multi-National, Randomized Study on PFO Closure in Stroke Patients using GORE® HELEX Septal Occluder Versus Medical Management

GORE HELEX Septal Occluder
The GORE HELEX Septal Occluder is a permanently implanted prosthesis and catheter delivery system indicated for the transcatheter closure of ostium secundum atrial septal defects (ASDs).

FDA Approves GORE HELEX Septal Occluder for Treatment of Atrial Septal Defect
03 October 2007 - W. L. Gore & Associates today announced that the US Food & Drug Administration (FDA) granted approval for the GORE HELEX Septal Occluder with modified catheter delivery system indicated for the transcatheter closure of atrial septal defect (ASD).